A Supreme Court decision in 2012 established that most clinical lab test services are based on natural phenomena, and therefore excluded as patentable subject matter. Are clinical lab tests patentable?Ī: No (with rare exceptions). Very rarely, a service that is very similar to existing services can be validated and implemented in a shorter time. How long does it take to implement a clinical lab test service?Ī: The validation and implementation process usually takes 1 to 2 years, but can take longer. In other situations, there may be more information or preliminary work necessary to determine if a new technology is ready for translation to a diagnostic test. If all relevant information is available the researcher and CARET consultant may decide to move forward with validation after the initial meeting. Each evaluation is unique and tailored to the researcher, technology, and potential diagnostic impact. CARET consultants are usually able to schedule an initial meeting within two weeks of being assigned a request. CARET consultants are faculty with experience in research, diagnostic test validation, and clinical diagnostics. How long will the evaluation take?Ī: After the initial request is complete the CARET director will assign the request to a CARET consultant, usually within a week. The CARET unit also provides fee-based consultation services to non-BBI researchers and companies. Who can ask for a CARET consultation?Ī: Anyone who thinks they have developed technology that could be used in medical diagnosis and is affiliated with BBI sponsor institutions, the University of Washington, Fred Hutchinson Cancer Research Center, and Seattle Children’s can request a CARET consultation. The purpose is to provide expert consultation to researchers interested in translating emerging technology into the clinical diagnostics. There are over 10 clinical laboratories that are part of the BBI Precision Diagnostics Platform with over 40 affiliated faculty experts in clinical diagnostic test development. The CARET unit provides free consultation services to BBI-affiliated researchers on the potential of new diagnostic approaches for use in clinical testing at BBI-affiliated laboratories, supports pilot studies for testing such methods with human samples, and helps translate of new tests into clinical care. Request a CARET consultation with: Brian Shirts, MD, PhD Associate Director of Laboratory Medicine at CARET FAQ: What is CARET?Ī: The Clinical Application of Research in Emerging Technologies unit is a service to help basic science and medical researchers translate their ideas into diagnostic tests. Our goal is to help translation of new tests into clinical care in partnership with BBI-affiliated laboratories. We support for pilot studies for test validation human samples. The BBI CARET unit provides evaluation and consultation services for BBI-affiliated researchers on the potential of newly developed diagnostic approaches for use in clinical testing. Some of the Platform Initiatives: Clinical Application of Research in Emerging Technologies Colin Pritchard, MD, PhD, Associate Professor of Laboratory Medicine at the University of Washington. The Precision Diagnostics Platform is overseen by Dr. It is a Pilot Granting Program for clinical lab test development. This platform provides test branding, marketing, and other services that are not core capabilities of the individual labs, as well as formal consultative services for the development of clinical diagnostics.
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